Senior Manufacturing Engineer

1 week ago

Calgary, Canada Fluid Biomed Inc. Full time

This is a unique opportunity to join an early-stage company to advance the development of a novel implantable medical device, ensuring its readiness for human use. Fluid Biomed is an innovative medical device startup focused on developing a cutting-edge neurovascular stent to treat brain aneurysms and enhance patient outcomes worldwide.

 

Key Responsibilities: 

  • Coordinate activities with external material suppliers and manufacturing providers including prototyping, evaluation of first articles, fabrication scale up, etc.
  • Specify, source, procure, install, qualify, and calibrate equipment required to support the manufacturing, testing, processing and storage of components and product.
  • Study existing processes to implement improvements on new products.
  • Participate in risk evaluation on stent and delivery system processes using Failure Modes and Effects Analysis (FMEA) methodology and execute follow-up testing required to provide evidence of mitigation.
  • Complete and review technical reports to document results and provide traceable evidence per requirements of company Quality Management System.
  • Partner with R&D, Quality, Manufacturing, Regulatory and other cross functional partners to complete manufacturing improvement projects to enhance process capability, maintainability, instrument assembly capability, or instrument output performance.
  • Document and execute equipment/process validation protocols & reports.
  • Lead and provide guidance to team members, with potential responsibilities for team leadership.
  • Drive DFM/A and future design decisions by data driven interactions across entire value stream (component, sub-assembly, final assembly).
  • Lead robust design transfer strategy from development throughout product commercialization phases to ensure scalability from day 1 of launch.
  • Lead end to end process solution deployment, from feasibility to verification/validation, including creating fixturing/tooling for Manufacturing & Assembly processes.
  • Explore, design and drive technology, equipment and process selection and deployment of automation solutions to stream-line various processes: including, but not limited to braiding, mandrel preparation, laser welding, extrusions, tipping, soldering, metal wire grinding, injection molding, final inspection, and pouching/boxing/label printing processes.

 

Education and Experience Requirements:

  • A minimum of 3-5 years of related working experience.
  • A minimum of a Bachelors degree in an Engineering field
  • Knowledge of good manufacturing practices and documentation.
  • Knowledge of a combination of process engineering tools such as DOE’s, Statistical Methods, CAD (Solid-works), GD&T, Process Simulation, Failure Analysis Techniques (Fault tree, Fish Bone Diagram).
  • The ability to influence others to achieve business objectives, and excellent written and oral communication skills.
  • Experience in a regulated industry; medical device experience is a plus.
  • Demonstrated experience working and communicating with internal and external partners, including vendors and suppliers of direct materials and services
  • Technical writing to include protocols, testing results, procedures, project status & special reports
  • Experience in managing product, project, and process risks
  • Knowledge of computer programs in addition to Microsoft office products.
  • Self-starter with a proven track record to engage in proactive learning and remain productive with minimal direction.
  • Must be highly organized with the ability to lead multiple projects/tasks simultaneously and effectively prioritize projects and tasks
  • Experience in process/product validations.
  • Hands-on experience with basic laboratory/shop operations.
  • Strong technical writing skills to complete documentation in timely fashion.
  • Prior leadership experience in managing a team of any capacity.

 

Additional Skills:

·        Excellent documentation, communication, time management, and interpersonal relationship skills.

·        Ability to adhere to Quality Management Systems requirements (ISO 13485).

·        Ability to manage competing priorities in a fast-paced environment.

 

Preferred Skills & Experience:

  • Experience in the development of medical devices
  • Experience in quality engineering activities such as FMEA, CAPA, and NC
  • Knowledge of In Process Control acceptance
  • Knowledge of ISO and cGMP regulations
  • A certification in Process Excellence (Green Belt or Black Belt)
  • Effective team interpersonal skills, along with conflict analysis & resolution experience

 

Role will be located physically on-site in Calgary, Alberta and candidates must be legally entitled to work full-time in Canada.

 

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